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Item 2 — Management's Discussion and Analysis
Profound Medical Corp. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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As used in this Quarterly Report on Form 10-Q, the “Company”, the “Registrant”, “we” or “us” refer to Profound Medical Corp. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes that appear elsewhere in this report. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, assumptions and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the Risk Factors section of the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2026, and elsewhere in this report under “Part II, Other Information—Item 1A, Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies and operations, financing plans, potential growth opportunities, potential market opportunities, potential results of our development efforts or trials, and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s plans, estimates, assumptions and beliefs only as of the date of this report. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Unless stated otherwise, all references to “$” are to United States dollars in thousands and all references to “C$” are to Canadian dollars in thousands.
Overview
We are a commercial-stage medical device company focused on the development and marketing of AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue utilizing our platform technologies and leveraging the healthcare system’s existing imaging infrastructure. Our lead product (the “TULSA-PRO system”) combines real-time MRI, robotically driven transurethral sweeping-action thermal ultrasound with closed-loop temperature feedback control for the ablation of prostate tissue. The product is comprised of one-time-use devices and capital equipment that are used in conjunction with a customer’s existing MRI scanner.
We are commercializing TULSA-PRO, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA procedure, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. TULSA employs real-time MR guidance for pixel-by-pixel precision to preserve prostate disease patients’ urinary continence and sexual function, while killing the targeted prostate tissue via a precise sound absorption technology that gently heats it to kill temperature (55-57°C). TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is generally no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).
We are also commercializing Sonalleve, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. We are in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
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Results of Operations
Comparison of Three and Six Months Ended June 30, 2026 and 2025
The following selected financial information as of and for the three and six months ended June 30, 2026 and 2025 have been derived from the unaudited consolidated financial statements and should be read in conjunction with those unaudited consolidated financial statements and related notes.
For the six months ended June 30,
2026 2025
$ $
Revenue 7,820 4,832
Operating expenses 24,866 28,443
Other (income) expense (2,574) 1,342
Net loss for the period 16,593 26,419
Basic and diluted loss per share 0.46 0.88
For the three months ended June 30,
2026 2025 Change
$ $ $ %
Revenue 2,483 2,211 272 12 %
Cost of sales 536 593 (57) (10) %
Gross profit 1,947 1,618 329 20 %
Gross margin
Expenses
Research and development 5,654 6,098 (444) (7) %
Selling, general and administrative 7,359 9,326 (1,967) (21) %
Total operating expenses 13,013 15,424 (2,411) (16) %
Other (income) expense
Net finance (income) expense (336) (343) 7 (2) %
Net foreign exchange (gain) loss (1,245) 2,168 (3,413) (157) %
Total other (income) expense (1,581) 1,825 (3,406) (187) %
Net loss before income taxes 9,485 15,631 (6,146) (39) %
Income taxes 55 64 (9) (14) %
Net loss attributed to shareholders for the period 9,540 15,695 (6,155) (39) %
Other comprehensive (income) loss
Item that may be reclassified to profit or loss
Foreign currency translation adjustment 950 (2,713) 3,663 (135) %
Net loss and comprehensive loss for the period 10,490 12,982 (2,492) (19) %
Loss per share
Basic and diluted net loss per common share 0.26 0.52 (0.26) (50) %
Basic and diluted weighted average common shares outstanding 36,350,665 30,053,142
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For the six months ended June 30,
2026 2025 Change
$ $ $ %
Revenue 7,820 4,832 2,988 62 %
Cost of sales 2,041 1,361 680 50 %
Gross profit 5,779 3,471 2,308 66 %
Gross margin
Expenses
Research and development 10,916 10,906 10 —
Selling, general and administrative 13,950 17,537 (3,587) (20) %
Total operating expenses 24,866 28,443 (3,577) (13) %
Other (income) expense
Net finance (income) expense (713) (788) 75 (10) %
Net foreign exchange (gain) loss (1,861) 2,130 (3,991) (187) %
Total other (income) expense (2,574) 1,342 (3,916) (292) %
Net loss before income taxes 16,513 26,314 (9,801) (37) %
Income taxes 80 105 (25) (24) %
Net loss attributed to shareholders for the period 16,593 26,419 (9,826) (37) %
Other comprehensive (income) loss
Item that may be reclassified to profit or loss
Foreign currency translation adjustment 1,955 (2,816) 4,771 (169) %
Net loss and comprehensive loss for the period 18,548 23,603 (5,055) (21) %
Loss per share
Basic and diluted net loss per common share 0.46 0.88 (0.42) (48) %
Basic and diluted weighted average common shares outstanding 36,324,393 30,055,047
Key Components of Our Results of Operations
Revenue
We deploy a hybrid revenue business model in the United States to market TULSA-PRO by charging for the system separately as capital and an additional charge for the one-time-use devices. The Sonalleve product is marketed primarily outside North America deploying a one-time capital sales model with limited recurring service revenue. Outside of North America, we generate most of our revenues from our system sales (both TULSA-PRO and Sonalleve) in Europe and Asia where we deploy a hybrid business model, charging for the system separately as capital and an additional charge for the one-time-use devices. Revenue is comprised of (a) recurring – non-capital revenue, which consists of the sale of one-time-use devices and services associated with maintenance contracts and (b) capital equipment, which is the one-time sale of capital equipment and the lease of capital equipment.
For the three months ended June 30, 2026, we recorded revenue totaling $2,483, consisting of $871 from the one-time sale of capital equipment and $1,612 from recurring – non-capital revenue. For the three months ended June 30, 2025, we recorded revenue of $2,211, consisting of $650 from the one-time sale of capital equipment and $1,561 from recurring – non-capital revenue. The increase of $272, or 12%, in revenue for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was the result of higher recurring revenue and capital sales overseas during the second quarter of 2026.
For the six months ended June 30, 2026, we recorded revenue totaling $7,820, consisting of $3,734 from the one-time sale of capital equipment and $4,086 from recurring – non-capital revenue. For the six months ended June 30, 2025, we recorded revenue of $4,832, consisting of $1,470 from the one-time sale of capital equipment and $3,362 from recurring – non-capital revenue. The increase
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of $2,988, or 62%, in revenue for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was driven by higher capital sales in the United States and overseas.
Cost of Sales
Cost of sales primarily includes the cost of finished goods, depreciation of equipment under lease, inventory write-downs, royalties, warranty expenses, freight and direct overhead and labor expenses necessary to acquire or manufacture the finished goods.
For the three months ended June 30, 2026, we recorded a cost of sales of $536, related to the sale of medical devices, capital and non-capital, which reflects 78% gross profit. For the three months ended June 30, 2025, we recorded a cost of sales of $593, which reflects a 73% gross profit. The decrease of $57, or 10%, in cost of sales for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was the result of the sale of multiple systems under existing operating leases to customers. The gross profit was higher in the three months ended June 30, 2026 by $329, or 20%, due to growth in the number of one-time-use devices sold.
For the six months ended June 30, 2026, we recorded a cost of sales of $2,041, related to the sale of medical devices, capital and non-capital, which reflects a 74% gross profit. For the six months ended June 30, 2025, we recorded a cost of sales of $1,361, which reflects a 72% gross profit. The increase of $680, or 50%, in cost of sales for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was the result of a different product combination whereby more capital equipment was sold which contains a higher margin. The gross profit was higher in the six months ended June 30, 2026 by $2,308, or 66%, due to growth in the number of capital systems sold.
Operating Expenses
Operating expenses consist of two components: research and development (“R&D”) and selling, general and administrative (“SG&A”).
R&D Expenses
R&D expenses are comprised of costs incurred in performing R&D activities, including new product development, continuous product improvement, investment in clinical trials and related manufacturing costs, materials and supplies, salaries and benefits, consulting fees, patent procurement costs, and occupancy costs related to R&D activity.
For the three months ended June 30, 2026, R&D expenses decreased by $444, or 7%, to $5,654 compared to $6,098 for the three months ended June 30, 2025. The decrease in R&D expenses was largely due to a reduction in clinical trial costs due to CAPTAIN trial enrollment completion. Offsetting these costs was an increased headcount, travel expenditures and higher consulting expenditures due to spending on R&D initiatives to reduce product costs and improve quality and efficiencies of our products.
For the six months ended June 30, 2026, R&D expenses increased by $10, or nil%, to $10,916 compared to $10,906 for the six months ended June 30, 2025. The increase in R&D expenses was largely due to increased headcount, travel expenditures and higher consulting expenditures due to spending on R&D initiatives to reduce product costs and improve quality and efficiencies of our products. Offsetting these costs were a reduction in clinical trial costs due to CAPTAIN trial enrollment completion.
These expenses emphasize our commitment to the ongoing development and improvement of the products while further demonstrating the commitment to a reliable and customizable product.
SG&A expenses
Selling, general and administrative expenses are comprised of business development costs related to the market development activities and commercialization of our systems, including salaries and benefits, marketing support functions, occupancy costs, insurance, various management and administrative support functions and other miscellaneous marketing and management costs.
SG&A expenses for the three months ended June 30, 2026 decreased by $1,967, or 21%, to $7,359 compared to $9,326 for the three months ended June 30, 2025. The decrease in SG&A was primarily due to decreased salary and commission expenses related to lower headcount in sales force, a reduction in travel expenses, an overall discount in our insurance premiums for the same coverage from the prior year and a reduction in bad debt expense. Offsetting these expenses was an increase in promotion and marketing expenses.
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SG&A expenses for the six months ended June 30, 2026 decreased by $3,587, or 20%, to $13,950 compared to $17,537 for the six months ended June 30, 2025. The decrease in SG&A was primarily due to decreased salaries and commission payments, a reduction in consulting fees and travel expenses, an overall discount in our insurance premiums for the same coverage from the prior year and a reduction in bad debt expense. Offsetting these expenses was an increase in promotion and marketing expenses.
Net finance income
Net finance income is primarily comprised of the following: (i) the CIBC Credit Agreement (as defined herein) accreting to the principal amount repayable and its related interest expense; and (ii) interest income from cash.
Net finance income decreased by $7 to ($336) during the three months ended June 30, 2026, compared to ($343) during the three months ended June 30, 2025. The decrease in net finance income was primarily due to a decrease in interest income from cash.
Net finance income decreased by $75 to ($713) during the six months ended June 30, 2026, compared to ($788) during the six months ended June 30, 2025. The decrease in net finance income was primarily due to a decrease in interest income from cash.
Net foreign exchange (gain) loss
Net foreign exchange (gain) loss is primarily comprised of the change in the foreign exchange rates for the Company’s foreign currency denominated cash, trade receivables and accounts payable.
Net foreign exchange (gain) loss decreased by $3,413 to ($1,245) during the three months ended June 30, 2026, compared to $2,168 during the three months ended June 30, 2025. The decrease in net foreign exchange (gain) loss was primarily due to an increase in the EUR and USD currency rates.
Net foreign exchange (gain) loss decreased by $3,991 to ($1,861) during the six months ended June 30, 2026, compared to $2,130 during the six months ended June 30, 2025. The decrease in net foreign exchange (gain) loss was primarily due to an increase in the EUR and USD currency rates.
Liquidity and Capital Resources
As of June 30, 2026, we had cash of $38,271 compared to $59,723 as of December 31, 2025. Historically, our primary source of cash has been financing activities, e.g., equity offerings as well as the CIBC Loan (as defined below).
Based on our current operating plans, we expect that our existing cash and sales of our products and services will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of the issuance of these unaudited consolidated financial statements. During that time, we expect that our expenses will increase, primarily due to the continued commercialization of TULSA-PRO and Sonalleve. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.
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Use of Proceeds
2025 Offering and non-brokered private placement
We received net proceeds of $40,801 from the public offering and the private placement (together, the “2025 Offering”) completed in December 2025. We intend to use net proceeds from the 2025 Offering to fund the continued commercialization of the TULSA-PRO system in the United States, the continued development and commercialization of the TULSA-PRO system and the Sonalleve system globally and for working capital and general corporate purposes. In addition, there have been no material adjustments to the cost or timing of the business objective previously disclosed in such prospectus supplement.
Total spending of proceeds
from the 2025
Offering as of
June 30, 2026
$
TULSA-PRO commercialization 17,075
Sonalleve development and commercialization 4,269
Working capital and general corporate purposes 5,563
Total 26,907
CIBC Loan
On March 3, 2025, we entered into an amended and restated credit agreement (the “CIBC Credit Agreement”) with Canadian Imperial Bank of Commerce (“CIBC”), which amended the terms of the loan with CIBC (the “CIBC Loan”) and the existing long-term debt provided under the original credit agreement with CIBC was repaid with proceeds from a new revolving line of credit provided by CIBC to us. The line of credit bears interest at the Wall Street Journal Prime Rate subject to a floor of 6.25%. Following an amendment to the CIBC Credit Agreement on September 30, 2025, the amended financial covenants are that unrestricted cash is at all times greater of: (i) to the extent that EBITDA is a negative number or loss for the most recent six-month period, the amount of such loss, or (ii) $10,000, reported on a monthly basis and that revenue for the 12 month period must be 15% greater than revenue for the same period in the prior fiscal year, reported on a quarterly basis. We are in compliance with these financial covenants as of June 30, 2026. Future compliance with the financial covenants included in the CIBC Credit Agreement is dependent upon achieving certain revenue, EBITDA, and anticipated unrestricted cash levels.
The obligations are secured by, inter alia, a general security agreement over our assets and the assets of our subsidiaries. The revolving line of credit matures on March 3, 2027 and provides an option to increase the amount of the revolving commitment by $5,000 within 18 months from March 3, 2025, subject to achieving a minimum trailing 12 month revenue exceeding $15,000. The exercise of the option would result in the size of the revolving commitment increasing from $10,000 to a maximum of $15,000. Additionally, the CIBC Credit Agreement provides that we may request a one-time increase in the principal amount of the revolving line of credit up to a maximum amount of $10,000, which is subject to the approval of CIBC in its sole discretion.
Cash Flows
The following table summarizes our cash flows for each of the periods presented (in thousands):
Six months ended June 30,
2026 2025
$ $
Cash provided by (used in) operating activities (19,921) (22,027)
Cash provided by (used in) financing activities — (290)
Foreign exchange on cash (1,531) 2,600
Net increase (decrease) in cash (21,452) (19,717)
Operating Activities
Net cash used in operating activities for the six months ended June 30, 2026 was $(19,921), primarily attributable to a net loss of $16,593 and $5,593 in net operating assets and liabilities, partially offset by $2,265 of non-cash charges. The cash used in operating
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activities was primarily due to the increased efforts supporting the commercialization and expansion of our products. This resulted in an increase in marketing and promotion fees and increased travel. Non-cash charges consisted primarily of share-based compensation, amortization and depreciation.
Net cash used in operating activities for the six months ended June 30, 2025 was $(22,027). The principal use of the operating cash flows during the period related to a net loss of $26,419 and an increase in net operating assets and liabilities of $1,616 and non-cash charges of $2,776. The cash used in operating expenses was primarily due to the increased efforts supporting the commercialization and expansion of our products. This resulted in an increase in headcount, travel, clinical trial costs and marketing fees. Non-cash charges consisted primarily of share-based compensation, amortization and depreciation.
Financing Activities
Net cash provided by (used in) financing activities for the six months ended June 30, 2026 was $nil.
Net cash provided by (used in) financing activities for the six months ended June 30, 2025 was $(290) from the repayments of long-term debt principal.
Foreign Exchange on Cash
Cash was impacted by the change in the foreign exchange rates for the Company’s foreign currency denominated cash. The value of our currencies decreased, resulting in a decrease in our cash holdings.
Funding Requirements
Based on our current operating plans, we expect that our existing cash and sales of our products and services will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of the issuance of these unaudited consolidated financial statements. During that time, we expect that our expenses will increase, primarily due to the continued commercialization of TULSA-PRO and Sonalleve.
We manage liquidity risk by monitoring actual and projected cash flows. A cash flow forecast is performed regularly to ensure that we have sufficient cash to meet our operational needs while maintaining sufficient liquidity. Our cash requirements depend on numerous factors, including market acceptance of our products, the resources devoted to developing and supporting the products and other factors. We expect to continue to devote substantial resources to expand procedure adoption and acceptance of our products.
We may require additional capital to fund R&D activities and any significant expansion of operations. Potential sources of capital could include equity and/or debt financings, development agreements or marketing agreements, the collection of revenue resulting from future commercialization activities and/or new strategic partnership agreements to fund some or all costs of development. There can be no assurance that we will be able to obtain the capital sufficient to meet any or all of our needs. The availability of equity or debt financing will be affected by, among other things, the results of R&D, our ability to obtain regulatory approvals, the market acceptance of our products, the state of the capital markets generally, strategic alliance agreements and other relevant commercial considerations. In addition, if we raise additional funds by issuing equity securities, existing security holders will likely experience dilution, and any incurring of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants that would restrict operations. Any failure on our part to raise additional funds on terms favorable to us or at all may require us to significantly change or curtail current or planned operations in order to conserve cash until such time, if ever, that sufficient proceeds from operations are generated, and could result in us not being in a position to take advantage of business opportunities, in the termination or delay of clinical trials for our products, in curtailment of product development programs designed to identify new products, in the sale or assignment of rights to technologies, product and/or an inability to file market approval applications at all or in time to competitively market products.
Critical Accounting Policies and Estimates
There have been no significant changes to our critical accounting policies since December 31, 2025. For a description of critical accounting policies that affect our significant judgments and estimates used in the preparation of our unaudited condensed consolidated financial statements, refer to Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report on Form 10-K dated March 5, 2026.
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Recent Accounting Pronouncements
See Note 2 to our Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.